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FDA 510(k)

HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)

K-Number: K912369 · 1991-10-11

ApplicantBiomet, Inc.
Decision Date1991-10-11
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K912369. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)?

HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Biomet, Inc.. The 510(k) number is K912369.

When did HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) receive FDA 510(k) clearance?

HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) received FDA 510(k) clearance on 1991-10-11, under 510(k) number K912369.

Who is the listed applicant for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)?

The FDA product code for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) is MEH.

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Related Devices (Code: MEH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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